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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Directory / Orthopedics & Spine

Orthopedics & Spine

ArthroTAK

Orlando, FL · Unknown · 510(k) cleared

Orlando, Florida orthopedic startup making a sutureless PEEK tendon anchor for soft tissue to bone fixation. Its first 510(k), K252635, was cleared in May 2026 for biceps tenodesis, and a second clearance announced in September 2026 added lateral extra-articular tenodesis in the knee.

FDA DECISIONS ON FILE

2 IN THE TRACKER

Decision	Number	Device	Applicant	Panel	Code
Sep 2, 26	K262809510(k)	ArthroTAK Tendon Anchor Kit	ArthroTAK, LLC	Orthopedic	MBI
May 1, 26	K252635510(k)	ArthroTAK Tendon Anchor Kit	ArthroTAK, LLC	Orthopedic	MBI

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ArthroTAK

FDA DECISIONS ON FILE

COVERAGE